BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURELY YOURS

    MDR report key: 5108761 · Received September 28, 2015

    Report

    Report Number
    3009974348-2015-00175
    Event Type
    Injury
    Date Received
    September 28, 2015
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    AMEDA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PARAMEDIC

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER WAS SENT A REPLACEMENT PURELY YOURS MOTOR BASE ON 06/05/2014 AND WAS ASKED TO RETURN ORIGINAL MOTOR BASE TO AMEDA, INC. FOR EVALUATION. A (B)(6) RETURN LABEL WAS PROVIDED FOR PRODUCT RETURN. 3 PHONE CALLS WERE MADE TO THE CUSTOMER REQUESTING RETURN OF THE PRODUCT. AS OF THIS DATE, PRODUCT HAS NOT BEEN RETURNED TO AMEDA, INC. FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE FILED IF PRODUCT IS RETURNED.

    Description of Event or Problem · 1

    AS PART OF AMEDA, INC.'S QUALITY MANAGEMENT SYSTEM ACTIVITIES, A REVIEW OF HISTORICAL COMPLAINTS WAS CONDUCTED. IT WAS DETERMINED THAT THIS COMPLAINT SHOULD HAVE BEEN REPORTED TO FDA. CUSTOMER CONTACTED AMEDA, INC. ON 06/05/2014 TO REPORT THE PURELY YOURS BREAST PUMP SHE USES DOES NOT DRAIN HER BREASTS WELL OF MILK AND LEAVES THEM VERY FULL. CUSTOMER STATES A DIAGNOSIS OF MASTITIS DURING THE TIME OF PUMPING WITH THE PURELY YOURS PUMP FOR 48 HOUR PERIODS WHEN WORKING AND AWAY FROM HER BABY. SHE REPORTS A DROP OF SUCTION WHEN THE DIAPHRAGMS STICK AND DO NOT RELEASE. SHE REPORTS A DECREASE IN MILK OUTPUT DUE TO LOW SUCTION LEADING TO A BREAST INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640054 PURELY YOURS ELECTRIC BREAST PUMP HGX AMEDA, INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other